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WS/T 491-2024: Guideline of non-treponemal tests for syphilis
Status: Valid WS/T 491: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| WS/T 491-2024 | English | 439 |
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Guideline of non-treponemal tests for syphilis
| Valid |
WS/T 491-2024
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| WS/T 491-2016 | English | 719 |
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Guideline of test method of non-specific antibodies for treponemal pallidum infection
| Obsolete |
WS/T 491-2016
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PDF similar to WS/T 491-2024
Basic data | Standard ID | WS/T 491-2024 (WS/T491-2024) | | Description (Translated English) | Guideline of non-treponemal tests for syphilis | | Sector / Industry | Health Industry Standard (Recommended) | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.020 | | Word Count Estimation | 20,283 | | Date of Issue | 2024-05-09 | | Date of Implementation | 2024-11-01 | | Older Standard (superseded by this standard) | WS/T 491-2016 | | Issuing agency(ies) | National Health Commission | | Summary | This standard specifies the technical requirements for non-specific antibody detection of syphilis. This standard is applicable to relevant institutions that carry out non-specific antibody testing for syphilis. | WS/T 491-2016: Guideline of test method of non-specific antibodies for treponemal pallidum infection
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Guideline of test method of non-specific antibodies for treponemal pallidum infection
ICS 11.020
C50
People's Republic of China health industry standards
Syphilis non-specific antibody testing instructions
2016-07-07 released
2016-12-15 Implementation
The People's Republic of China Health and Family Planning Commission released
Directory
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Abbreviations 1
5 detection principle 1
5.1 Principle 1
5.2 Method 2
6 instrument supplies 2
6.1 Micropipettor 2
6.2 Level Rotator 2
6.3 Sample Collection 3
6.4 Sample Container 3
6.5 reaction plate 3
6.6 dedicated antigen drop 3
7 sample collection and preservation 3
7.1 Acquisition and processing 3
7.2 Sample Inspection 4
7.3 Save 4
8 test procedures 4
8.1 General Description 4
8.2 RPR/T RUST - Qualitative test 5
8.3 RPR/T RUST - Semi-quantitative test 5
8.4 VDRL test 5
9 Results description and representation 7
9.1 Qualitative test 7
9.2 Semi-quantitative test 7
9.3 Report Formats
10 Quality Control 7
10.1 Basic Requirements 7
10.2 Reference 8
Control Article 8
10.4 reaction plate 8
10.5 dedicated drip 9
10.6 Results Determination 9
10.7 Indoor Quality Control and Room Quality Evaluation 9
11 Clinical Significance 9
11.1 Auxiliary diagnosis 9
11.2 Efficacy monitoring 9
12 limitations 10
12.1 Overview 10
12.2 False Positives 10
12.3 False negative reaction 10
12.4 Pre-banding phenomenon 10
12.5 Serum fixation 10
12.6 Plasma Sample 10
Appendix A (Normative) Initial assessment of anti-jamming performance 11
Appendix B (Normative) Anti-jamming performance evaluation --- Verify Manufacturer's Statement 12
Reference 13
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was drafted. Shanghai Dermatology Hospital, Shanghai Clinical Laboratory Center, Zhongshan Hospital Affiliated to Fudan University, China Disease Prevention
Control Center STD Control Center, Shanghai Center for Disease Control and Prevention.
Drafters of this standard. Gu Weiming, Yang Yang, Wang Qingzhong, Guo Wei, Yin Yueping, Wu Lei, Xue Yile.
Syphilis non-specific antibody testing instructions
1 Scope
This standard specifies the methods of non-specific detection of syphilis antibodies, test procedures, the results described and said quality control.
This standard applies to carry out non-specific syphilis antibody testing of various types of laboratories.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
JJG646-2006 pipette
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Serum fixed serofast
A small number of patients after sufficient treatment of plum-treated syphilis non-specific antibodies maintained at a relatively constant low titers.
Note 1. Determine the serum fixed, should have three elements. epidemiological history and clinical manifestations to rule out recurrence, re-infection; continuous 2 follow-up cycle (≥ June)
Serum antibodies are maintained at low titers within the range of ± 1 titers (typically ≤1. 8), ie the direction of the trend of change is unknown; there is no technical and
Methodological error.
Note 2. Some patients may be life-long serum fixation phenomenon.
4 Abbreviations
The following abbreviations apply to this document.
CSF. cerebrospinal fluid
RCF. relative centrifugal force (relativecentrifugalforce)
RPR. Rapid plasma cyclins card test (rapidplasmareagincirclecardtest)
TRUST. toluidine red unheated serum test
VDRL. venereal disease research laboratory test
5 detection principle
5.1 principle
Infection with Treponema pallidum, damaged host cells and Treponema pallidum itself release of lipid-like substances, causing the host to produce IgA,
IgM and IgG anti-lipid antibodies, this antibody in vitro and artificial according to a certain proportion of the configuration of cardiolipin, lecithin and cholesterol
The original solution to produce flocculation phenomenon, the aggregation of different reaction intensity and antibody concentration is positively correlated to a certain extent, anti
Reflection of the status of syphilis infection.
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